VITROS 5600 INTEGRATED SYSTEM 6802413

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-09 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[82772975] The investigation determined that non-reproducible, higher and lower than expected vitros valp quality control results were obtained from non-vitros biorad control fluids and vitros tdm performance verifiers, using vitros valp reagent lot 2511-25-5503 processed using a vitros 5600 integrated system (s/n (b)(4)). The likely assignable cause of the higher and lower than expected valp results is an issue related to the vitros 5600 system as the results of a within run precision test performed using vitros gent reagent were marginal indicating an issue with the performance of the vitros 5600 system. Following service actions, (which included cleaning the cuvette incubator, replacement of the micro-immunoassay and sample pump with appropriate adjustments), acceptable within run gent precision results were obtained indicating service actions had returned the vitros 5600 system to the expected performance. There is no indication that the vitros valp reagent lot 2511-25-5503 contributed to this event as based on historical vitros valp quality control results the reagent is performing as expected.
Patient Sequence No: 1, Text Type: N, H10

[82772976] A customer obtained non-reproducible, higher and lower than expected vitros valp quality control results from non-vitros biorad control fluids and vitros tdm performance verifiers, using vitros valp reagent processed using a vitros 5600 integrated system. Biorad lot 31830 level 1 results 43. 60, 17. 53 versus expected 30. 64 ug/ml, biorad lot 31830 level 2 result 93. 90 versus expected 132. 69 ug/ml, tdm pv lot n5702 level 2 result 45. 69 versus expected 68. 9 ug/ml, tdm pv lot h5125 level 3 lot h5125 result 73. 19 versus expected 106. 4 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. The customer made no allegations that patient sample results were affected. There was no report of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1319681-2017-00061
• MDR Report Key: 6776237
• Date Received: 2017-08-09
• Date of Report: 2017-08-09
• Date of Event: 2017-07-16
• Date Mfgr Received: 2017-07-17
• Device Manufacturer Date: 2016-08-10
• Date Added to Maude: 2017-08-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: MEDICAL TECHNOLOGIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. JAMES A STEVENS
• Manufacturer Street: 100 INDIGO CREEK DRIVE
• Manufacturer City: ROCHESTER NY 14626
• Manufacturer Country: US
• Manufacturer Postal: 14626
• Manufacturer Phone: 5854533000
• Manufacturer G1: ORTHO-CLINICAL DIAGNOSTICS
• Manufacturer Street: 100 INDIGO CREEK DRIVE
• Manufacturer City: ROCHESTER NY 14626
• Manufacturer Country: US
• Manufacturer Postal Code: 14626
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Generic Name: CHEMISTRY ANALYZER
• Product Code: LEG
• Date Received: 2017-08-09
• Catalog Number: 6802413
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
• Manufacturer Address: 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626

Device Sequence Number: 1

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Generic Name: CHEMISTRY ANALYZER
• Product Code: JJE
• Date Received: 2017-08-09
• Catalog Number: 6802413
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
• Manufacturer Address: 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-08-09